Institut Cardiovasculaire Paris Sud, Paris, France.
EuroIntervention. 2012 Jul 20;8(3):325-35. doi: 10.4244/EIJV8I3A51.
SPIRIT Women is the first interventional trial dedicated exclusively to women, focusing on symptoms at presentation, referral time to coronary intervention and the safety and performance of the XIENCE V stent.
SPIRIT Women is a prospective, open-label, multicentre study in which 1,573 women were enrolled at 73 sites outside the United States. The primary endpoint is the composite of all death, Academic Research Consortium (ARC) defined myocardial infarction (MI) and target vessel revascularisation (TVR) at one year. Data collected included symptoms at presentation and referral to coronary intervention. To allow comparison by gender, the latter were compared to data from male patients from the SPIRIT V study. The one- and two-year composite of all death, MI and TVR was 12% and 15%, respectively. Target lesion revascularisation (TLR) and stent thrombosis (definite and probable) rates were 2.4% and 0.59%, respectively, at one year and 3.6% and 0.73%, at two years. The total referral time for coronary intervention in women was four days longer than for men in the SPIRIT V study.
The XIENCE V stent is safe and effective with low TLR and stent thrombosis rates. More efforts remain to be made to increase the awareness of women and physicians of the risk for coronary artery disease (CAD).
SPIRIT Women 是首个专门针对女性的介入性试验，重点关注发病时的症状、向冠状动脉介入治疗转诊的时间以及 XIENCE V 支架的安全性和性能。
SPIRIT Women 是一项前瞻性、开放标签、多中心研究，在美国以外的 73 个地点招募了 1573 名女性。主要终点是一年时的所有死亡、学术研究联合会（ARC）定义的心肌梗死（MI）和靶血管血运重建（TVR）的复合终点。收集的数据包括发病时的症状和向冠状动脉介入治疗的转诊情况。为了能够按性别进行比较，将后者与 SPIRIT V 研究中男性患者的数据进行比较。一年时的所有死亡、MI 和 TVR 的复合终点分别为 12%和 15%，两年时分别为 15%和 18%。一年时的靶病变血运重建（TLR）和支架血栓形成（明确和可能）发生率分别为 2.4%和 0.59%，两年时分别为 3.6%和 0.73%。女性冠状动脉介入治疗的总转诊时间比 SPIRIT V 研究中的男性长 4 天。
XIENCE V 支架安全有效，TLR 和支架血栓形成发生率低。仍需做出更多努力，以提高女性和医生对冠心病（CAD）风险的认识。
